Browse Device Recalls
2,945 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,945 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 2,945 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 21, 2024 | The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model ... | Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a speci... | Class II | Abbott Medical |
| Nov 21, 2024 | SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used... | Software issues were identified in application version 2.x. | Class II | Medtronic Neuromodulation |
| Nov 21, 2024 | SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used... | Software issues were identified in application version 2.x. | Class II | Medtronic Neuromodulation |
| Nov 20, 2024 | StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. ... | A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone... | Class I | Nova Biomedical Corporation |
| Nov 20, 2024 | StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number... | A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone... | Class I | Nova Biomedical Corporation |
| Nov 20, 2024 | Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216 | The following four issues are included: 1. Certain Channel Settings may result in an Access Poi... | Class II | Philips North America Llc |
| Nov 20, 2024 | StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescri... | A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of errone... | Class I | Nova Biomedical Corporation |
| Nov 16, 2024 | Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344. | Potential for a plan box not updated issue during Interventional procedure with Spectral CT that ... | Class II | Philips North America Llc |
| Nov 15, 2024 | Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K2401... | The warming surfaces or incubator well temperatures of the listed products may exceed the desired... | Class II | CooperSurgical, Inc. |
| Nov 15, 2024 | Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number:... | The warming surfaces or incubator well temperatures of the listed products may exceed the desired... | Class II | CooperSurgical, Inc. |
| Nov 15, 2024 | Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: ... | The warming surfaces or incubator well temperatures of the listed products may exceed the desired... | Class II | CooperSurgical, Inc. |
| Nov 15, 2024 | mint Lesion, Software Versions: 3.10.0 and 3.10.1. | Some software versions have a malfunction where they may show incorrect orientation labels for a... | Class II | Mint Medical GmbH |
| Nov 15, 2024 | mint Lesion, Software Versions: 3.9.0 through 3.9.5. | Some software versions have a malfunction where they may show incorrect orientation labels for a... | Class II | Mint Medical GmbH |
| Nov 15, 2024 | Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number:... | The warming surfaces or incubator well temperatures of the listed products may exceed the desired... | Class II | CooperSurgical, Inc. |
| Nov 15, 2024 | Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number... | The warming surfaces or incubator well temperatures of the listed products may exceed the desired... | Class II | CooperSurgical, Inc. |
| Nov 14, 2024 | BD Pyxis MedStation ES, REF: 323 | Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or ... | Class II | CareFusion 303, Inc. |
| Nov 14, 2024 | BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324 | Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or ... | Class II | CareFusion 303, Inc. |
| Nov 14, 2024 | BD Pyxis CII Safe ES, REF: 1116-00 | Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or ... | Class II | CareFusion 303, Inc. |
| Nov 1, 2024 | Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, U... | On October 18, 2024, BD has identified through customer complaints and an increase in field failu... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| Nov 1, 2024 | FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 ... | On October 18, 2024, BD has identified through customer complaints and an increase in field failu... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| Nov 1, 2024 | FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 ... | On October 18, 2024, BD has identified through customer complaints and an increase in field failu... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| Nov 1, 2024 | FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD... | On October 18, 2024, BD has identified through customer complaints and an increase in field failu... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| Nov 1, 2024 | Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjuncti... | Certain software versions will not notify end users of calls initiated by call points with the Ar... | Class II | Securitas Healthcare LLC |
| Oct 31, 2024 | BD EpiCenter Data Management System, Multi User Software Version or Model: 4... | BD confirmed that product service credentials used by some BD technical support teams to access c... | Class II | Becton Dickinson & Co. |
| Oct 31, 2024 | Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Rec... | Due a potential software/configuration issue that may result is incorrect alignment during recons... | Class II | Hermes Medical Solutions AB |
| Oct 31, 2024 | BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: ... | BD confirmed that product service credentials used by some BD technical support teams to access c... | Class II | Becton Dickinson & Co. |
| Oct 29, 2024 | Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small ... | Due to manufacturing defects observed on Locking Caps that affect the ability for components to m... | Class II | SEASPINE ORTHOPEDICS CORPORATION |
| Oct 29, 2024 | Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small... | Due to manufacturing defects observed on Locking Caps that affect the ability for components to m... | Class II | SEASPINE ORTHOPEDICS CORPORATION |
| Oct 18, 2024 | Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software | Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions re... | Class II | LivaNova Deutschland GmbH |
| Oct 15, 2024 | Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 S... | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use o... | Class I | Draeger Medical, Inc. |
| Oct 15, 2024 | Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 ... | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use o... | Class I | Draeger Medical, Inc. |
| Oct 10, 2024 | Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software... | A software issue affecting Philips Vue PACS may cause incorrect ischemic map and table value calc... | Class II | Philips Medical Systems Technologies Ltd. |
| Oct 2, 2024 | Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code... | The door on the Spectrum IQ Infusion pump may not be able to fully close. | Class II | Baxter Healthcare Corporation |
| Oct 1, 2024 | Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merl... | Due to heart transmitter not being able to upgrade to the current software version in the field a... | Class III | Abbott Medical |
| Oct 1, 2024 | Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is i... | Due to heart transmitter not being able to upgrade to the current software version in the field a... | Class III | Abbott Medical |
| Sep 30, 2024 | Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Numbe... | For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been ... | Class III | Zyno Medical LLC |
| Sep 24, 2024 | Brand Name: Vial2Bag Advanced¿ Product Name: Vial2Bag Advanced¿ 20mm Admixtu... | Due to packaging damage from heat exposure during shipping/transportation that may result in a br... | Class II | West Pharmaceutical Services AZ, Inc. |
| Sep 18, 2024 | Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Na... | To better define the drying procedures described in the IFU to improve the instructions for easie... | Class II | Olympus Corporation of the Americas |
| Sep 17, 2024 | Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reus... | Due to pin coming off of handles. | Class II | MicroSurgical Technology Inc |
| Sep 17, 2024 | The IMAGEnet 6 Ophthalmic Data System is a software program that is intended ... | The overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in th... | Class II | Topcon Medical Systems, Inc. |
| Sep 13, 2024 | Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Softwar... | There is a defect in the air-in-line software algorithm. | Class I | Zyno Medical LLC |
| Sep 13, 2024 | Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Num... | Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from t... | Class II | Olympus Corporation of the Americas |
| Sep 12, 2024 | BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.... | Synapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilizing the in-line breakpoint f... | Class II | Becton Dickinson & Co. |
| Sep 11, 2024 | Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sh... | Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the devi... | Class II | Olympus Corporation of the Americas |
| Sep 6, 2024 | The FLUOROspeed is intended to be used as a universal diagnostic imaging syst... | X-ray R/F system software with certain versions of the control board may occasionally fail to dis... | Class II | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION |
| Sep 6, 2024 | SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitabl... | X-ray R/F system software with certain versions of the control board may occasionally fail to dis... | Class II | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION |
| Sep 6, 2024 | Enterprise Imaging XERO Viewer- software application used for reference and d... | Software defect, when an image has non-square pixel spacing, the reference/localizer line is inco... | Class II | Agfa Healthcare NV |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.